FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medtronic Model 5392 External Pulse Generator (EPG)
K Number: K201011
·
Decision May 13, 2020
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
64
Applicant Total
209
Review Days
26
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Basic Information
- Device Name
- Medtronic Model 5392 External Pulse Generator (EPG)
- K Number
- K201011
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- April 17, 2020
- Decision Date
- May 13, 2020
- Product Code
- DTE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | FDA class 2 | Cardiovascular |
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